U34 Multi-center Clinical Studies

Implementation Planning Cooperative Agreement

The NIDDK supports investigator-initiated, multi-center clinical studies through a two part process:

an implementation planning phase (U34), followed by

a cooperative agreement (U01) to conduct the study.

This policy applies to all clinical studies, interventional trials as well as observational studies, conducted at three or more centers. A study is considered to be "multi-center" if three or more sites are involved in the actual conduct of the study. A study will not be considered to involve multiple centers if participant recruitment occurs at three or more locations but all interventions and/or outcomes assessments are performed by a single study team.

U34 at the NIDDK

NIDDK supports implementation planning cooperative agreements (U34) for multi-center clinical studies. Proposed studies should be hypothesis-driven and focus on a disease relevant to the mission of NIDDK. Proposals are expected to improve understanding, diagnosis, prevention or treatment of the disease being studied.

The U34 is intended to support all administrative study group activities that are required in order to begin recruitment of subjects. These activities include, but are not limited to: establishing the research team, developing the tools for data management and oversight of the research, defining the recruitment strategies, finalizing the protocol and investigators brochure, writing the Manual of Operations, establishing a data and safety monitoring plan and initiating the IRB approval process. The U34 is not designed for the collection of preliminary data, for the conduct of pilot studies to support the rationale for a clinical study, or for the design of the study. The U34 application will include the proposed study design, a full protocol and a budget for the clinical study to be conducted under the U01.

The U34 will provide up to two years of support. U34 applications will be peer reviewed by special emphasis panels set up by the NIDDK Review Branch.

A successful U34 will result in an application (U01) to conduct the clinical study. It is expected that receipt of a U34 will lead to the timely submission of an application for support of the full-scale study, incorporating the elements developed during the planning phase. Prospective applicants should note that funding of a U34 does not guarantee or imply funding for a subsequent application.

How to Apply

Read the Program Announcement

More detailed instructions regarding the U34 application process are contained in the following program announcement: PAR-15-068

Contact Program Staff At Least 12 Weeks Prior to Submission

All applicants are strongly encouraged to contact NIDDK program staff at least 12 weeks before submitting a U34 application. Program staff will help the investigator understand whether the proposed full clinical study addresses a high priority research area and meets programmatic needs including balance across research areas, whether it is appropriate to conduct using this mechanism, and whether funds might be available for the subsequent, full clinical study.

Since this is a cooperative agreement, NIDDK will ultimately have substantive scientific involvement with the proposed project. NIDDK will need sufficient time to thoroughly consider the proposed study. It is the Institute’s experience that applications for multi-center clinical studies may be scientifically meritorious but often need further work before they are ready for submission. Allowing as much time as possible for the consultation process will allow time for revisions, should they need to be made.

Include Appropriate Details in Your Letter

Your written request for prior consultation should be as succinct as possible. The details included in your letter may vary depending on the type of study planned (e.g., epidemiology study, drug trial, behavior intervention). Generally, the letter should include all of the following items:

Date of Proposed Submission

Study title

Study PI (attach biosketch)

Primary institution

Specific Aims

Significance

Summary of study protocol, including flow diagram depicting study

Summary of safety/risk issues

Proposed start date, duration, and timeline of the clinical trial

Estimated sample size including brief power calculation

General statistical assumptions for the proposed study design and analysis

Potential collaborating sites, including the demographics and availability of the study population at those sites. Include identification and a brief description of the Data Coordinating Center

Discussion of product/intervention to be evaluated and how it will be obtained, if applicable, including industry partner(s) and regulatory issues that have/need to be resolved

Total cost for the U34 phase

Total cost estimate of the clinical study, not the planning grant, by year

Milestones to be accomplished during the U34

Consider Other Funding Mechanisms: R01 and R21

The NIDDK will not accept applications for multi-center clinical studies that are submitted as R01s, with the exception of ancillary studies to existing cooperative agreements, which can be submitted as R01s to PAR-12-265: Ancillary Studies to Major Ongoing Clinical Research Studies to Advance Areas of Scientific Interest within the Mission of the NIDDK (R01), or applications submitted in response to other/future FOAs that specifically invite multi-center clinical studies. This policy does not apply to pilot studies. Investigators who are interested in obtaining support for pilot studies may use the R21 mechanism, through the appropriate program announcement. View open R21 FOAs from NIDDK.